Drug · FAERS side-effect profile with label screen
Atazanavir side effects: what 14,285 FDA adverse event reports show
Drug class
Protease inhibitor
FDA label, Indications wording
Brand names
Reyataz
openFDA label
Who reports
14,285 reports · 89% serious · 1,065 with death outcome · 37% female
openFDA FAERS counts, all years, deduplication not applied
Used for
REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus .
FDA label, Indications and Usage
What it is
The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 1Lab value / disease marker 2Not in label — unassessed 35
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,024 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Congenital naevus | 45 | 723.7 506.2–1,034.6ROR 726.0 · χ² 21,171 / p <1e-300 | 400.3 EB05 311.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 82% (drug 37%) | no trial data cached |
| Supernumerary nipple | 26 | 710.0 444.2–1,134.9ROR 711.3 · χ² 11,879 / p <1e-300 | 352.7 EB05 253.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 37%) | no trial data cached |
| Aids encephalopathy | 15 | 504.9 280.6–908.6ROR 505.4 · χ² 5,225 / p <1e-300 | 253.7 EB05 163.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Csf hiv escape syndrome | 29 | 385.1 255.8–579.8ROR 385.9 · χ² 8,474 / p <1e-300 | 253.6 EB05 185.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Acoustic stimulation tests abnormal | 29 | 335.8 224.3–502.8ROR 336.5 · χ² 7,588 / p <1e-300 | 231.3 EB05 168.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 37%) | no trial data cached |
| Aids dementia complex | 10 | 283.8 144.1–558.9ROR 284.0 · χ² 2,125 / p <1e-300 | 163.9 EB05 95.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Alpha 1 foetoprotein abnormal | 16 | 275.7 161.6–470.4ROR 276.0 · χ² 3,451 / p <1e-300 | 181.8 EB05 118.6 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Progressive external ophthalmoplegia | 16 | 204.9 121.4–345.8ROR 205.2 · χ² 2,668 / p <1e-300 | 148.2 EB05 96.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Pulmonary haemorrhage neonatal | 11 | 201.5 107.3–378.6ROR 201.7 · χ² 1,755 / p <1e-300 | 135.9 EB05 81.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Mitochondrial toxicity | 95 | 191.8 154.9–237.4ROR 193.0 · χ² 15,752 / p <1e-300 | 163.9 EB05 138.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=95 · ♀ 7% (drug 37%) | no trial data cached |
| Lipodystrophy acquired | 236 | 182.7 159.7–208.9ROR 185.7 · χ² 37,702 / p <1e-300 | 160.2 EB05 143.8 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=228 · ♀ 15% (drug 37%) | no trial data cached |
| Ultrasound antenatal screen abnormal | 24 | 177.2 116.0–270.7ROR 177.5 · χ² 3,591 / p <1e-300 | 140.6 EB05 99.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Heterotaxia | 17 | 165.1 100.0–272.7ROR 165.3 · χ² 2,344 / p <1e-300 | 127.4 EB05 84.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Bone demineralisation | 104 | 159.5 130.3–195.1ROR 160.6 · χ² 14,609 / p <1e-300 | 140.1 EB05 118.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=97 | no trial data cached |
| Hiv-associated neurocognitive disorder | 11 | 159.2 85.4–296.7ROR 159.3 · χ² 1,419 / p <1e-300 | 115.4 EB05 68.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Psychiatric decompensation | 180 | 149.2 128.1–173.8ROR 151.1 · χ² 23,891 / p <1e-300 | 133.5 EB05 117.9 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=179 · ♀ 2% (drug 37%) · 93% clinician | no trial data cached |
| Cushing's syndrome | 61 | 139.0 107.0–180.7ROR 139.6 · χ² 7,502 / p <1e-300 | 122.2 EB05 98.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=61 | no trial data cached |
| Chordee | 12 | 137.8 76.3–249.1ROR 138.0 · χ² 1,366 / p 2e-299 | 105.3 EB05 64.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Low set ears | 35 | 134.7 95.3–190.4ROR 135.1 · χ² 4,129 / p <1e-300 | 115.7 EB05 87.0 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=35 · ♀ 100% (drug 37%) | no trial data cached |
| Renal dysplasia | 29 | 119.9 82.1–175.1ROR 120.2 · χ² 3,049 / p <1e-300 | 103.4 EB05 75.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Blood bilirubin unconjugated increased | 51 | 113.0 85.1–150.2ROR 113.4 · χ² 5,150 / p <1e-300 | 101.0 EB05 79.8 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=43 · 93% clinician | no trial data cached |
| Foetal chromosome abnormality | 12 | 112.1 62.3–201.6ROR 112.1 · χ² 1,125 / p 6e-247 | 89.7 EB05 54.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Single umbilical artery | 25 | 105.5 70.3–158.3ROR 105.7 · χ² 2,315 / p <1e-300 | 91.7 EB05 65.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=25 | no trial data cached |
| Renal colic | 150 | 103.9 88.1–122.6ROR 105.0 · χ² 14,172 / p <1e-300 | 95.9 EB05 83.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=150 | no trial data cached |
| Congenital hydrocephalus | 30 | 91.2 63.1–131.9ROR 91.4 · χ² 2,434 / p <1e-300 | 81.6 EB05 59.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 62% (drug 37%) | no trial data cached |
| Placental infarction | 13 | 90.0 51.4–157.6ROR 90.1 · χ² 995 / p 1e-218 | 75.7 EB05 47.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Immune reconstitution syndrome | 75 | 89.3 70.7–112.6ROR 89.7 · χ² 6,083 / p <1e-300 | 82.4 EB05 67.9 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=74 | no trial data cached |
| Fanconi syndrome acquired | 100 | 88.9 72.7–108.7ROR 89.5 · χ² 8,107 / p <1e-300 | 82.5 EB05 69.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=99 · 92% clinician | no trial data cached |
| Kaposi's sarcoma | 29 | 88.6 60.9–128.8ROR 88.7 · χ² 2,284 / p <1e-300 | 79.3 EB05 57.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 0% (drug 37%) · 91% clinician | no trial data cached |
| Virologic failure | 300 | 86.4 77.0–97.0ROR 88.2 · χ² 23,820 / p <1e-300 | 81.2 EB05 73.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=298 · 96% clinician | no trial data cached |
| Psychomotor skills impaired | 144 | 85.1 72.0–100.6ROR 85.9 · χ² 11,222 / p <1e-300 | 79.6 EB05 69.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=144 · ♀ 3% (drug 37%) · 96% clinician | no trial data cached |
| Trisomy 18 | 21 | 84.9 54.7–131.8ROR 85.0 · χ² 1,566 / p <1e-300 | 75.0 EB05 51.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Facial wasting | 14 | 81.4 47.5–139.4ROR 81.5 · χ² 978 / p 7e-215 | 70.0 EB05 44.3 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=14 | no trial data cached |
| Congenital skin dimples | 12 | 75.8 42.5–135.5ROR 75.9 · χ² 773 / p 3e-170 | 65.0 EB05 39.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Neonatal seizure | 12 | 73.3 41.0–130.9ROR 73.3 · χ² 747 / p 9e-165 | 63.1 EB05 38.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Calculus urinary | 73 | 73.2 57.9–92.5ROR 73.5 · χ² 4,878 / p <1e-300 | 68.5 EB05 56.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=73 | no trial data cached |
| Periventricular leukomalacia | 13 | 70.2 40.2–122.5ROR 70.3 · χ² 781 / p 3e-172 | 61.3 EB05 38.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Depression suicidal | 158 | 70.2 59.9–82.3ROR 71.0 · χ² 10,214 / p <1e-300 | 66.5 EB05 58.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=158 · ♀ 0% (drug 37%) · 96% clinician | no trial data cached |
| Lipoatrophy | 43 | 69.7 51.3–94.6ROR 69.9 · χ² 2,713 / p <1e-300 | 64.7 EB05 50.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 7% (drug 37%) | no trial data cached |
| Mitochondrial cytopathy | 20 | 69.1 44.1–108.2ROR 69.2 · χ² 1,217 / p 7e-267 | 62.3 EB05 42.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug interaction | 1,783 | 16.7 16.0–17.4ROR 18.9 · χ² 26,149 / p <1e-300 | 16.5 EB05 15.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · ♀ 15% (drug 37%) | no trial data cached |
| Depression | 1,317 | 8.5 8.1–9.0ROR 9.3 · χ² 8,756 / p <1e-300 | 8.4 EB05 8.1 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · ♀ 10% (drug 37%) | no trial data cached |
| Foetal exposure during pregnancy | 1,038 | 19.0 17.9–20.1ROR 20.4 · χ² 17,505 / p <1e-300 | 18.7 EB05 17.8 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.0 | no trial data cached |
| Anxiety | 868 | 4.5 4.2–4.8ROR 4.7 · χ² 2,365 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Maternal exposure during pregnancy | 749 | 12.6 11.7–13.5ROR 13.2 · χ² 7,924 / p <1e-300 | 12.4 EB05 11.7 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · ♀ 100% (drug 37%) | no trial data cached |
| Pain | 744 | 1.8 1.7–1.9ROR 1.8 · χ² 259 / p 2e-58 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 · 71% consumer | no trial data cached |
| Emotional distress | 651 | 7.9 7.3–8.5ROR 8.2 · χ² 3,919 / p <1e-300 | 7.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 100% consumer | no trial data cached |
| Anhedonia | 593 | 33.6 31.0–36.4ROR 35.0 · χ² 18,320 / p <1e-300 | 32.8 EB05 30.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · 100% consumer | no trial data cached |
| Abortion spontaneous | 513 | 18.9 17.4–20.6ROR 19.6 · χ² 8,606 / p <1e-300 | 18.7 EB05 17.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · ♀ 100% (drug 37%) | no trial data cached |
| Renal failure (kidney failure) | 474 | 5.2 4.8–5.7ROR 5.4 · χ² 1,615 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Nephrolithiasis (kidney stones) | 473 | 15.3 14.0–16.8ROR 15.8 · χ² 6,268 / p <1e-300 | 15.2 EB05 14.1 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Nausea | 468 | 0.9 0.8–1.0ROR 0.9 · χ² 9 / p 0.001 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | no trial data cached |
| Fatigue (tiredness) | 419 | 0.8 0.7–0.9ROR 0.8 · χ² 24 / p 6e-7 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 | no trial data cached |
| Chronic kidney disease | 401 | 7.7 7.0–8.5ROR 7.9 · χ² 2,333 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Osteoporosis | 399 | 14.4 13.0–15.8ROR 14.7 · χ² 4,903 / p <1e-300 | 14.2 EB05 13.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Congenital naevus — n=45, PRR 723.7
- Supernumerary nipple — n=26, PRR 710.0
- Csf hiv escape syndrome — n=29, PRR 385.1
- Acoustic stimulation tests abnormal — n=29, PRR 335.8
- Mitochondrial toxicity — n=95, PRR 191.8
- Lipodystrophy acquired — n=236, PRR 182.7
- Ultrasound antenatal screen abnormal — n=24, PRR 177.2
- Bone demineralisation — n=104, PRR 159.5
- Psychiatric decompensation — n=180, PRR 149.2
- Cushing's syndrome — n=61, PRR 139.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Atazanavir?
In FDA FAERS, the most frequently co-reported reaction terms for Atazanavir are depression, anxiety, pain, emotional distress, anhedonia, abortion spontaneous. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Atazanavir have an FDA boxed warning?
No. The FDA label retrieved for Atazanavir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atazanavir causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 165cff62-b284-4a27-a65d-9ec8a5bfcdd8, effective 20241205; matched on
openfda.generic_name.exact:"ATAZANAVIR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,064 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.